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ENROLLING BY INVITATION
NCT07872826
PHASE3

A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial was conducted to investigate the efficacy and safety of RF16001 local infiltration for analgesia after total hip arthroplasty. The primary objective was to evaluate the effectiveness of local infiltration of RF16001 for injection for postoperative analgesia after total hip arthroplasty. The secondary objective was to evaluate the safety of local infiltration of RF16001 for injection for analgesia after total hip arthroplasty.

Official title: To Evaluate the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty (THA) in a Multicenter, Randomized, Double-blind, Parallel, Positive and Placebo-controlled Phase Ⅲ Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-10-10

Completion Date

2027-10-31

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DRUG

RF16001 for injection

Before the surgical incision was closed, 30ml of 1.43% RF16001 for injection was administered by local infiltration around the incision by an unblinded physician

DRUG

Ropivacaine hydrochloride injection

Before the surgical incision was closed, an unblinded physician administered 30ml 0.5% ropivacaine hydrochloride injection by local infiltration around the incision

DRUG

0.9% sodium chloride injection

Before the surgical incision was closed, an unblinded physician administered 30ml 0.9% sodium chloride injection by local infiltration around the incision

Locations (1)

The Third Xiangya Hospital of Central South University, Changsha, hunan

Changsha, China